Eso-Sponge Registry

Completed

• Conditions: Leakage After Esophagectomy; Leakage After Gastrectomy; Perforation of the Esophagus
• Interventions: Device: Eso-SPONGE® vacuum treatment

• Registration Number: NCT02662777
• Lead Sponsor: Aesculap AG

Brief Summary

This international, prospective and multicenter registry was designed to collect clinical evidence for the endoscopic vacuum treatment using Eso-SPONGE® for anastomotic leakage after esophageal resection or iatrogenic or spontaneous esophageal perforation.

Detailed Description

Anastomotic Leakages or other defects in the upper gastrointestinal tract can have serious consequences for the affected patients. Different parameters, like the size, location, time to diagnosis of the lesion, but also the general condition of the patient, have a significant influence on the clinical outcome of the patient. Often this situation is accompanied by symptoms of sepsis and a significant morbidity rate with corresponding substantial mortality rate. For this reason the treatment of this clinical situation is often a challenge for the clinician.

Besides surgical examination and the endoscopic stent system, good experiences have been obtained with the Endo-SPONGE® therapy for the lower gastrointestinal tract. In the future the endoluminal vacuum therapy for the upper gastrointestinal is available, too, with Eso-SPONGE®.

Eso-SPONGE® represent an innovative therapy concept for the treatment of this problem in the upper gastrointestinal tract, which can contribute significantly to the reduction of morbidity and mortality of the patients.

The overall success rate of endoscopic esophageal vacuum therapy in the literature ranges from 80-100%. Currently only cohort studies including a small number of patients have been performed and published. Therefore an international, prospective and multicenter registry was designed to collect clinical evidence for Eso-SPONGE treatment concept in a large population under daily clinical routine.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2016-01-19
• Study First Submitted QC: 2016-01-21
• Study First Posted: 2016-01-26
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• Endoscopic vacuum therapy (EVT) of anastomotic leakage after esophageal resection or spontaneous or iatrogenic perforations
• age > 18 years
• written informed consent

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Eso-SPONGE® vacuum treatment	Eso-SPONGE® vacuum treatment	leakage after esophagectomy and gastrectomy, perforation of the esophagus

Primary Outcome Measures

Name	Time	Method
Healing rate of the esophageal anastomosis leakage or esophageal perforation	until day of discharge (approximately 2 weeks)	Reduction of the cavity, endoscopic vacuum therapy no longer necessary

Secondary Outcome Measures

Name	Time	Method
Number of Eso-SPONGE® changes	until day of discharge (approximately 2 weeks)
Total number of sponges used	until day of discharge (approximately 2 weeks)	Total number of Eso-SPONGE® units used until day of discharge
Average replacement intervals	until day of discharge (approximately 2 weeks)	Period of time between exchange of ESO-Sponge®
Duration of endoscopic vacuum therapy	until day of discharge (approximately 2 weeks)	Number of days during which Eso-SPONGE® was applied
Complication Rate	until day of discharge (approximately 2 weeks)	Number of Complications during endoscopic vacuum treatment (e.g. death, re-operations, stenosis, pneumonia, peritonitis, mediastinitis)

Trial Locations

Locations (17)

Klinikum Wilhelmshaven; 🇩🇪 Wilhelmshaven, Niedersachsen, Germany

Klinikum Herford; 🇩🇪 Herford, Hessen, Germany

Städtisches Krankenhaus Heinsberg; 🇩🇪 Heinsberg, Germany

Universitätsklinikum Kiel; 🇩🇪 Kiel, Schleswig-Holstein, Germany

Universitätsklinikum Freiburg; 🇩🇪 Freiburg, Germany

Klinikum Lüneburg, Klinik für Allgemein-, Viszeral- & Thoraxchirurgie; 🇩🇪 Lüneburg, Niedersachsen, Germany

Wald-Klinikum Gera; 🇩🇪 Gera, Thüringen, Germany

Augusta-Kliniken GmbH; 🇩🇪 Bochum, Nordrhein-Westfalen, Germany

EVK Herne; 🇩🇪 Herne, Nordrhein-Westfalen, Germany

Krankenhaus der Augustinerinnen; 🇩🇪 Köln, Germany

Sankt Katharinen Krankenhaus; 🇩🇪 Frankfurt, Hessen, Germany

Asklepios Klinik; 🇩🇪 Lich, Hessen, Germany

St. Johannes-Hospital Dortmund; 🇩🇪 Dortmund, Nordrhein-Westfalen, Germany

Zentralklinik Bad Berka; 🇩🇪 Bad Berka, Germany

Universitätsmedizin Greifswald; 🇩🇪 Greifswald, Germany

Universitätsklinikum Tübingen; 🇩🇪 Tübingen, Germany

Siloah St. Trudpert Klinikum; 🇩🇪 Pforzheim, Baden-Württemberg, Germany